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Trial NCT00916188

Resource URI: http://static.linkedct.org/resource/trials/NCT00916188
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/38400>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/38401>
linkedct:brief_title Effects of Black Tea on Type 2 Diabetes
linkedct:condition <http://static.linkedct.org/resource/condition/13331>
linkedct:criteria Inclusion Criteria: - Clinical diagnosis of type 2 diabetes mellitus Exclusion Criteria: - Intake of antioxidant supplements during previous six months
linkedct:description A total of 45 patients of known T2DM (16 males and 29 females) were introduced into the controlled clinical trial and randomly assigned to either test (57.0 ± 7.9 yrs, n=23) or control (55.4 •± 8.3 yrs, n=22) group. Patients in control group were instructed to have only one cup (150 ml) of black tea/day, as a 2.5 g tea bag that had to be prepared in a standard way for one week (washout period). Patients in the test group were instructed to have 300, 450, and 600 ml (2, 3, and 4 cups, respectively) in weeks 2, 3 and 4 respectively. We assessed the change in serum glutathion, superoxidismutase, total antioxidant capacity, FBS, CRP, HbA1C, lipid profiles and fibrinogen during the end of each week.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age N/A
linkedct:end_date November 2007
linkedct:enrollment 45 (xsd:int)
linkedct:firstreceived_date June 8, 2009
linkedct:id NCT00916188
linkedct:intervention <http://static.linkedct.org/resource/intervention/70690>
rdfs:label Trial NCT00916188
linkedct:lastchanged_date June 8, 2009
linkedct:lead_sponsor_agency National Nutrition and Food Technology Institute
linkedct:location <http://static.linkedct.org/resource/location/328636>
linkedct:nct_id NCT00916188
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Effects of Black Tea Consumption on Oxidative Stress, Serum Lipid Profile and Insulin Sensitivity in Patients With Type 2 Diabetes
linkedct:org_study_id P/25/47/4564
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/58889>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/1388>
foaf:page <http://clinicaltrials.gov/show/NCT00916188>
linkedct:phase N/A
linkedct:primary_completion_date December 2006
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/43968>
linkedct:source National Nutrition and Food Technology Institute
linkedct:start_date October 2006
linkedct:study_design Other, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary The primary objective of this study is to evaluate the efficacy of different doses of black tea (150, 300, 450, 600 ml) in the test group compared to 150 ml in the control group, in improving oxidative stress, lipid profiles and insulin sensitivity.
rdf:type linkedct:trials
linkedct:verification_date June 2009